[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bpdcn-relapsedrefractory-t-cell-acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bpdcn-relapsedrefractory-t-cell-acute-lymphoblastic-leukemia":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":5},"100633197","phase-1-adaptive-dual-target-car-t-cells-for-relapsed-or-refractory-hematologic-malignancies-100633197",false,"NCT07523555","Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies","A Phase 1\u002F2, Open-Label, Nonrandomized, Multi-arm Umbrella Study of Biomarker-Selected Dual-Target CAR-T Cell Modules in Adults With Relapsed or Refractory Hematologic Malignancies","ADAPT-HEM","Inclusion Criteria:\n\n* Age 18 to 75 years at the time of consent.\n* Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL\u002FCLL\u002FSLL; multiple myeloma\u002Fplasma cell leukemia; AML\u002Fhigh-risk MDS\u002FBPDCN; or T-ALL\u002FT-LBL\u002Fperipheral T-cell lymphoma.\n* Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative\u002Fapproved standard option judged appropriate by the investigator.\n* Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review.\n* Measurable or otherwise evaluable disease by disease-specific response criteria.\n* ECOG performance status 0 to 2.\n* Adequate organ function: LVEF \\>= 45%; creatinine clearance \\>= 40 mL\u002Fmin; AST\u002FALT \\\u003C= 3 x ULN; total bilirubin \\\u003C= 1.5 x ULN unless due to Gilbert syndrome; oxygen saturation \\>= 92% on room air.\n* Adequate hematologic reserve unless cytopenia is clearly disease-related.\n* Ability to undergo leukapheresis and willingness to comply with study procedures and follow-up.\n* If prior allogeneic HSCT: at least 100 days from transplant, no uncontrolled GVHD, and no systemic immunosuppression above physiologic steroid replacement.\n* Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception during protocol-defined risk periods.\n* Written informed consent obtained before any study-specific procedure.\n\nExclusion Criteria:\n\n* \\- Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.\n* Active symptomatic CNS involvement requiring escalating therapy; previously treated\u002Fstable CNS disease may be allowed if defined prospectively in the final protocol.\n* Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved \\>= Grade 3 toxicity from prior anticancer therapy\n* Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.\n* Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical\u002Finhaled therapy.\n* Prior solid organ transplant.\n* Clinically significant cardiovascular disease, uncontrolled arrhythmia, decompensated heart failure, myocardial infarction within 6 months, or recent stroke within 6 months.\n* Uncontrolled HIV, HBV, or HCV viremia.\n* Pregnancy or breastfeeding.\n* Another active malignancy requiring systemic therapy, unless low-risk and definitively treated per protocol-defined exceptions.\n* Known hypersensitivity to fludarabine, cyclophosphamide, or critical product excipients.\n* Inability to manufacture a releaseable CAR-T product or failure to meet module-specific product-release criteria.\n* Any medical, psychiatric, or social condition that, in the investigator's judgment, would increase risk, impair compliance, or confound interpretation of study results.","ALL","18 Years","75 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Phase 1\u002F2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies. After central antigen co-expression screening, participants are assigned to the most appropriate active dual-target module: CD19\u002FCD22, CD19\u002FCD20, BCMA\u002FCD19, BCMA\u002FCD38, BCMA\u002FGPRC5D, CD33\u002FCD123, CD33\u002FCLL1, or CD5\u002FCD7. Phase 1 determines safety, dose-limiting toxicities, and the recommended phase 2 dose for each module; phase 2 estimates preliminary antitumor activity, including overall response rate and MRD-negative response.\n\nLymphodepletion with fludarabine\u002Fcyclophosphamide precedes infusion. The design is intended to reduce antigen escape by matching disease biology and target co-expression to a rational dual-target strategy.",[29,30,31,32,33,34,35],"Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma or CLL\u002FSLL","Relapsed\u002FRefractory Multiple Myeloma or Plasma Cell Leukemia","Relapsed\u002FRefractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm","BPDCN; Relapsed\u002FRefractory T-cell Acute Lymphoblastic Leukemia","T-lymphoblastic Lymphoma","Peripheral T-cell Lymphoma",[37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"BCMA","biomarker-selected","CD19","CD20","CD22","CD33","CD38","CD123","CD5","CD7","CLL1\u002FCLEC12A","dual-target CAR-T","GPRC5D","hematologic malignancy","MRD negativity","antigen escape","umbrella trial","RECRUITING","2026-04-05",{"date":57,"type":58},"2026-04-13","ACTUAL",{"date":60,"type":58},"2026-03-02",{"date":62,"type":22},"2028-02-17",{"name":64,"class":65},"Beijing Biotech","INDUSTRY"]